81_FR_39171 81 FR 39056 - Menu Labeling Public Workshops; Public Meetings

81 FR 39056 - Menu Labeling Public Workshops; Public Meetings

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 81, Issue 115 (June 15, 2016)

Page Range39056-39057
FR Document2016-14138

The Food and Drug Administration (FDA or we) is announcing two public meetings to discuss menu labeling requirements. We will announce an additional public meeting to be held in Oakland, California, in a separate Federal Register notice later this year. The purpose of the public meetings is to help the regulated industry comply with the requirements of the menu labeling final rule.

Federal Register, Volume 81 Issue 115 (Wednesday, June 15, 2016)
[Federal Register Volume 81, Number 115 (Wednesday, June 15, 2016)]
[Notices]
[Pages 39056-39057]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-14138]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-N-0001]


Menu Labeling Public Workshops; Public Meetings

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public meetings.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA or we) is announcing two 
public meetings to discuss menu labeling requirements. We will announce 
an additional public meeting to be held in Oakland, California, in a 
separate Federal Register notice later this year. The purpose of the 
public meetings is to help the regulated industry comply with the 
requirements of the menu labeling final rule.

DATES: See ``How to Participate in the Public Meetings'' in the 
SUPPLEMENTARY INFORMATION section of this document for dates, times, 
and addresses of the public meetings, closing dates for advance 
registration, requesting special accommodations due to disability, and 
other information.

ADDRESSES: See ``How to Participate in the Public Meetings'' in the 
SUPPLEMENTARY INFORMATION section of this document.

FOR FURTHER INFORMATION CONTACT: 
    For questions about registering for this meeting or for special 
accommodations due to disability, contact Cindy de Sales, The Event 
Planning Group, 8720 Georgia Ave., Suite 801, Silver Spring, MD 20910, 
240-316-3207, FAX: 240-652-6002, and email: [email protected].
    For general questions about the public meetings, contact Loretta A. 
Carey, Center for Food Safety and Applied Nutrition (HFS-820), Food and 
Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, 
240-402-2371.

SUPPLEMENTARY INFORMATION:

I. Background

    In the Federal Register of December 1, 2014 (79 FR 71156), we 
published a final rule on nutrition labeling of standard menu items in 
restaurants and similar retail food establishments; the rule is 
codified at Title 21 of the Code of Federal Regulations, section 
101.11. The final rule implements section 403(q)(5)(H) of the Federal 
Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 343(q)(5)(H)), 
which, in general, requires that restaurants and similar retail food 
establishments that are part of a chain with 20 or more locations, 
doing business under the same name, and offering for sale substantially 
the same menu items, provide calorie information for standard menu 
items (including food on display and self-service food), provide, upon 
request, additional written nutrition information for standard menu 
items, and comply with other requirements described in section 
403(q)(5)(H) of the FD&C Act.
    On December 18, 2015, the President signed the Consolidated 
Appropriations

[[Page 39057]]

Act, 2016 (Pub. L. 114-113). Section 747 of the Consolidated 
Appropriations Act states that none of the funds made available under 
the Consolidated Appropriations Act may be used to implement, 
administer, or enforce the final rule entitled ``Food Labeling; 
Nutrition Labeling of Standard Menu Items in Restaurants and Similar 
Retail Food Establishments'' until 1 year after the date of publication 
of a Level 1 guidance with respect to nutrition labeling of standard 
menu items in restaurants and similar retail food establishments.
    In the Federal Register of May 5, 2016 (81 FR 27067), we announced 
the availability of the guidance for industry entitled ``A Labeling 
Guide for Restaurants and Retail Establishments Selling Away-From-Home 
Foods--Part II (Menu Labeling Requirements in Accordance with 21 CFR 
101.11).'' The guidance uses a question and answer format and is 
intended to help restaurants and similar retail food establishments 
covered by the final rule comply with the nutrition labeling 
requirements of the final rule. In accordance with the Consolidated 
Appropriations Act, 2016, enforcement of the final rule will commence 
May 5, 2017.
    We have made education of the menu labeling requirements a high 
priority and are announcing two menu labeling workshops to educate 
interested members of the public, especially the regulated industry, 
about the menu labeling requirements. Interested persons can continue 
to submit general questions to [email protected].

II. Purpose and Format of the Public Meetings

    The purpose of these public meetings is to help the regulated 
industry comply with the requirements of the menu labeling final rule. 
On the morning of day one of the meeting, we will present information 
on the menu labeling requirements. The afternoon of day one and all of 
day two will consist of consultation sessions with FDA staff where 
individual companies (limited to two members per company) may discuss 
their specific questions and concerns. Each consultation session is 
limited to 15 minutes to help ensure that enough time is available to 
accommodate each company that requests a consultation. We recommend 
that participants in the consultation session prepare their questions 
in advance due to the limited time available.

III. How To Participate in the Public Meetings

    We encourage all persons who wish to attend the meeting to register 
in advance of the meeting and to indicate whether they are requesting a 
consultation session. There is no fee to register for the public 
meeting, and registration will be on a first-come, first-served basis. 
Early registration is recommended to facilitate planning of the 
consultation sessions and because seating is limited. We encourage you 
to use electronic registration if possible (see the address in table 
1).
    Table 1 provides information on participation in the public 
meetings.

                                 Table 1--Information on Menu Labeling Meetings
----------------------------------------------------------------------------------------------------------------
             Activity                        Date              Electronic address               Address
----------------------------------------------------------------------------------------------------------------
First public meeting..............  July 7 and 8, 2016, 8  ..........................  Harvey Wiley Building,
                                     a.m. to 4:30 p.m.                                  5100 Paint Branch Pkwy.,
                                                                                        College Park, MD 20740.
                                                                                       Note: The Prince George's
                                                                                        County Planning Board
                                                                                        recently approved a
                                                                                        request to change the
                                                                                        street name from ``Paint
                                                                                        Branch Parkway'' to
                                                                                        ``Campus Drive.'' This
                                                                                        change is expected to
                                                                                        occur on July 1, 2016.
Advance registration..............  by June 30, 2016.....  http://www.cvent.com/d/     We encourage you to use
                                                            zfq6sm.                     electronic registration
                                                                                        if possible.\1\
Request special accommodations due  by June 30, 2016.....  ..........................  See FOR FURTHER
 to a disability.                                                                       INFORMATION CONTACT.
Second public meeting.............  September 27 and 28,   ..........................  Robert A. Young Federal
                                     2016, 8 a.m. to 4:30                               Building, 1222 Spruce
                                     p.m.                                               St., St. Louis, MO
                                                                                        63103.
Advance registration..............  by September 20, 2016  http://www.cvent.com/d/     We encourage you to use
                                                            zfq6sm.                     electronic registration
                                                                                        if possible.\1\
Request special accommodations due  by September 13, 2016  ..........................  See FOR FURTHER
 to a disability.                                                                       INFORMATION CONTACT.
----------------------------------------------------------------------------------------------------------------
\1\ You may also register via mail, fax, or email. Please include your name, title, firm name, address, and
  phone and fax numbers in your registration information and send to: Cindy de Sales, The Event Planning Group,
  8720 Georgia Ave., Suite 801, Silver Spring, MD 20910, 240-316-3207, FAX: 240-652-6002, and email:
  [email protected].

IV. Transcripts

    Transcripts of the workshop will not be prepared.

    Dated: June 10, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-14138 Filed 6-14-16; 8:45 am]
BILLING CODE 4164-01-P



                                             39056                            Federal Register / Vol. 81, No. 115 / Wednesday, June 15, 2016 / Notices

                                                                                       TABLE 2—NEW ENTRIES TO THE LIST OF RECOGNIZED STANDARDS
                                              Recognition No.                                                   Title of standard 1                                                         Reference No. and date

                                                                                                                                 A. General I

                                             5–102 .................   Graphical symbols for use on equipment .................................................................   IEC 60417:2002 DB.
                                             5–103 .................   Graphical symbols for use on equipment—Registered symbols ..............................                   ISO 7000: Fifth edition 2014–01–15.
                                             5–104 .................   Graphical symbols for electrical equipment in medical practice ...............................             IEC/TR 60878 Ed. 3.0 b:2015.
                                                1 All   standard titles in this table conform to the style requirements of the respective organizations.


                                             IV. List of Recognized Standards                               site on the Internet for easy access to                       DATES:  See ‘‘How to Participate in the
                                                FDA maintains the Agency’s current                          information including text, graphics,                         Public Meetings’’ in the SUPPLEMENTARY
                                             list of FDA Recognized Consensus                               and files that you may download to a                          INFORMATION section of this document
                                             Standards in a searchable database that                        personal computer with access to the                          for dates, times, and addresses of the
                                             may be accessed directly at FDA’s                              Internet. Updated on a regular basis, the                     public meetings, closing dates for
                                             Internet site at http://                                       CDRH home page, http://www.fda.gov/                           advance registration, requesting special
                                             www.accessdata.fda.gov/scripts/cdrh/                           MedicalDevices, includes a link to                            accommodations due to disability, and
                                             cfdocs/cfStandards/search.cfm. FDA                             standards-related documents including                         other information.
                                             will incorporate the modifications and                         the guidance and the current list of                          ADDRESSES: See ‘‘How to Participate in
                                             revisions described in this notice into                        recognized standards. After publication                       the Public Meetings’’ in the
                                             the database and, upon publication in                          in the Federal Register, this notice                          SUPPLEMENTARY INFORMATION section of
                                             the Federal Register, this recognition of                      announcing ‘‘Modification to the List of                      this document.
                                             consensus standards will be effective.                         Recognized Standards, Recognition List                        FOR FURTHER INFORMATION CONTACT:
                                             FDA will announce additional                                   Number: 042’’ will be available at http://                      For questions about registering for
                                             modifications and revisions to the list of                     www.fda.gov/MedicalDevices/                                   this meeting or for special
                                             recognized consensus standards, as                             DeviceRegulationandGuidance/                                  accommodations due to disability,
                                             needed, in the Federal Register, once a                        Standards/ucm123792.htm. You may                              contact Cindy de Sales, The Event
                                             year or more often if necessary.                               access ‘‘Guidance on the Recognition                          Planning Group, 8720 Georgia Ave.,
                                             Beginning with Recognition List: 033,                          and Use of Consensus Standards,’’ and                         Suite 801, Silver Spring, MD 20910,
                                             FDA no longer announces minor                                  the searchable database for ‘‘FDA                             240–316–3207, FAX: 240–652–6002,
                                             revisions to the list of recognized                            Recognized Consensus Standards,’’ at                          and email: rsvp@tepgevents.com.
                                             consensus standards such as technical                          http://www.fda.gov/MedicalDevices/                              For general questions about the public
                                             contact person, devices affected,                              DeviceRegulationandGuidance/                                  meetings, contact Loretta A. Carey,
                                             processes affected, Code of Federal                            Standards.                                                    Center for Food Safety and Applied
                                             Regulations citations, and product                               Dated: June 8, 2016.
                                                                                                                                                                          Nutrition (HFS–820), Food and Drug
                                             codes.                                                                                                                       Administration, 5100 Paint Branch
                                                                                                            Leslie Kux,
                                                                                                                                                                          Pkwy., College Park, MD 20740, 240–
                                             V. Recommendation of Standards for                             Associate Commissioner for Policy.                            402–2371.
                                             Recognition by FDA                                             [FR Doc. 2016–13990 Filed 6–14–16; 8:45 am]
                                                                                                                                                                          SUPPLEMENTARY INFORMATION:
                                                Any person may recommend                                    BILLING CODE 4164–01–P
                                             consensus standards as candidates for                                                                                        I. Background
                                             recognition under section 514 of the                                                                                            In the Federal Register of December 1,
                                             FD&C Act by submitting such                                    DEPARTMENT OF HEALTH AND                                      2014 (79 FR 71156), we published a
                                             recommendations, with reasons for the                          HUMAN SERVICES                                                final rule on nutrition labeling of
                                             recommendation, to standards@                                                                                                standard menu items in restaurants and
                                                                                                            Food and Drug Administration                                  similar retail food establishments; the
                                             cdrh.fda.gov. To be properly considered,
                                             such recommendations should contain,                                                                                         rule is codified at Title 21 of the Code
                                                                                                            [Docket No. FDA–2016–N–0001]
                                             at a minimum, the following                                                                                                  of Federal Regulations, section 101.11.
                                             information: (1) Title of the standard, (2)                    Menu Labeling Public Workshops;                               The final rule implements section
                                             any reference number and date, (3)                             Public Meetings                                               403(q)(5)(H) of the Federal Food, Drug,
                                             name and address of the national or                                                                                          and Cosmetic Act (the FD&C Act) (21
                                             international standards development                            AGENCY:     Food and Drug Administration,                     U.S.C. 343(q)(5)(H)), which, in general,
                                             organization, (4) a proposed list of                           HHS.                                                          requires that restaurants and similar
                                             devices for which a declaration of                             ACTION:    Notice of public meetings.                         retail food establishments that are part
                                             conformity to this standard should                                                                                           of a chain with 20 or more locations,
                                             routinely apply, and (5) a brief                               SUMMARY:    The Food and Drug                                 doing business under the same name,
                                             identification of the testing or                               Administration (FDA or we) is                                 and offering for sale substantially the
                                             performance or other characteristics of                        announcing two public meetings to                             same menu items, provide calorie
                                             the device(s) that would be addressed                          discuss menu labeling requirements. We                        information for standard menu items
                                             by a declaration of conformity.                                will announce an additional public                            (including food on display and self-
ehiers on DSK5VPTVN1PROD with NOTICES




                                                                                                            meeting to be held in Oakland,                                service food), provide, upon request,
                                             VI. Electronic Access                                          California, in a separate Federal                             additional written nutrition information
                                               You may obtain a copy of ‘‘Guidance                          Register notice later this year. The                          for standard menu items, and comply
                                             on the Recognition and Use of                                  purpose of the public meetings is to                          with other requirements described in
                                             Consensus Standards’’ by using the                             help the regulated industry comply with                       section 403(q)(5)(H) of the FD&C Act.
                                             Internet. The Center for Devices and                           the requirements of the menu labeling                            On December 18, 2015, the President
                                             Radiological Health (CDRH) maintains a                         final rule.                                                   signed the Consolidated Appropriations


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                                                                          Federal Register / Vol. 81, No. 115 / Wednesday, June 15, 2016 / Notices                                                                        39057

                                             Act, 2016 (Pub. L. 114–113). Section 747                requirements of the final rule. In                                                two members per company) may discuss
                                             of the Consolidated Appropriations Act                  accordance with the Consolidated                                                  their specific questions and concerns.
                                             states that none of the funds made                      Appropriations Act, 2016, enforcement                                             Each consultation session is limited to
                                             available under the Consolidated                        of the final rule will commence May 5,                                            15 minutes to help ensure that enough
                                             Appropriations Act may be used to                       2017.                                                                             time is available to accommodate each
                                             implement, administer, or enforce the                     We have made education of the menu                                              company that requests a consultation.
                                             final rule entitled ‘‘Food Labeling;                    labeling requirements a high priority                                             We recommend that participants in the
                                             Nutrition Labeling of Standard Menu                     and are announcing two menu labeling                                              consultation session prepare their
                                             Items in Restaurants and Similar Retail                 workshops to educate interested                                                   questions in advance due to the limited
                                             Food Establishments’’ until 1 year after                members of the public, especially the                                             time available.
                                             the date of publication of a Level 1                    regulated industry, about the menu                                                III. How To Participate in the Public
                                             guidance with respect to nutrition                      labeling requirements. Interested                                                 Meetings
                                             labeling of standard menu items in                      persons can continue to submit general
                                             restaurants and similar retail food                     questions to CalorieLabeling@                                                        We encourage all persons who wish to
                                             establishments.                                         fda.hhs.gov.                                                                      attend the meeting to register in advance
                                                In the Federal Register of May 5, 2016                                                                                                 of the meeting and to indicate whether
                                                                                                     II. Purpose and Format of the Public                                              they are requesting a consultation
                                             (81 FR 27067), we announced the
                                                                                                     Meetings                                                                          session. There is no fee to register for
                                             availability of the guidance for industry
                                             entitled ‘‘A Labeling Guide for                            The purpose of these public meetings                                           the public meeting, and registration will
                                             Restaurants and Retail Establishments                   is to help the regulated industry comply                                          be on a first-come, first-served basis.
                                             Selling Away-From-Home Foods—Part                       with the requirements of the menu                                                 Early registration is recommended to
                                             II (Menu Labeling Requirements in                       labeling final rule. On the morning of                                            facilitate planning of the consultation
                                             Accordance with 21 CFR 101.11).’’ The                   day one of the meeting, we will present                                           sessions and because seating is limited.
                                             guidance uses a question and answer                     information on the menu labeling                                                  We encourage you to use electronic
                                             format and is intended to help                          requirements. The afternoon of day one                                            registration if possible (see the address
                                             restaurants and similar retail food                     and all of day two will consist of                                                in table 1).
                                             establishments covered by the final rule                consultation sessions with FDA staff                                                 Table 1 provides information on
                                             comply with the nutrition labeling                      where individual companies (limited to                                            participation in the public meetings.

                                                                                          TABLE 1—INFORMATION ON MENU LABELING MEETINGS
                                                      Activity                       Date                                       Electronic address                                                       Address

                                             First public meeting .....   July 7 and 8, 2016, 8            .........................................................................   Harvey Wiley Building, 5100 Paint Branch
                                                                            a.m. to 4:30 p.m.                                                                                            Pkwy., College Park, MD 20740.
                                                                                                                                                                                       Note: The Prince George’s County Planning
                                                                                                                                                                                         Board recently approved a request to
                                                                                                                                                                                         change the street name from ‘‘Paint Branch
                                                                                                                                                                                         Parkway’’ to ‘‘Campus Drive.’’ This change
                                                                                                                                                                                         is expected to occur on July 1, 2016.
                                             Advance registration ....    by June 30, 2016 .......     http://www.cvent.com/d/zfq6sm ......................                            We encourage you to use electronic registra-
                                                                                                                                                                                         tion if possible.1
                                             Request special ac-          by June 30, 2016 .......         .........................................................................   See FOR FURTHER INFORMATION CON-
                                               commodations due                                                                                                                          TACT.
                                               to a disability.
                                             Second public meeting        September 27 and 28,             .........................................................................   Robert A. Young Federal Building, 1222
                                                                            2016, 8 a.m. to 4:30                                                                                        Spruce St., St. Louis, MO 63103.
                                                                            p.m.
                                             Advance registration ....    by September 20,             http://www.cvent.com/d/zfq6sm ......................                            We encourage you to use electronic registra-
                                                                            2016.                                                                                                        tion if possible.1
                                             Request special ac-          by September 13,                 .........................................................................   See FOR FURTHER INFORMATION CON-
                                               commodations due             2016.                                                                                                        TACT.
                                               to a disability.
                                                1 You may also register via mail, fax, or email. Please include your name, title, firm name, address, and phone and fax numbers in your reg-
                                             istration information and send to: Cindy de Sales, The Event Planning Group, 8720 Georgia Ave., Suite 801, Silver Spring, MD 20910, 240–316–
                                             3207, FAX: 240–652–6002, and email: rsvp@tepgevents.com.


                                             IV. Transcripts                                         DEPARTMENT OF HEALTH AND                                                            The meetings will be closed to the
                                                                                                     HUMAN SERVICES                                                                    public in accordance with the
                                               Transcripts of the workshop will not                                                                                                    provisions set forth in sections
                                             be prepared.                                            National Institutes of Health                                                     552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
                                               Dated: June 10, 2016.                                                                                                                   as amended. The grant applications and
                                             Leslie Kux,
                                                                                                     Center for Scientific Review; Notice of                                           the discussions could disclose
ehiers on DSK5VPTVN1PROD with NOTICES




                                                                                                     Closed Meetings                                                                   confidential trade secrets or commercial
                                             Associate Commissioner for Policy.
                                             [FR Doc. 2016–14138 Filed 6–14–16; 8:45 am]                                                                                               property such as patentable material,
                                                                                                       Pursuant to section 10(d) of the
                                                                                                                                                                                       and personal information concerning
                                             BILLING CODE 4164–01–P                                  Federal Advisory Committee Act, as
                                                                                                                                                                                       individuals associated with the grant
                                                                                                     amended (5 U.S.C. App.), notice is
                                                                                                                                                                                       applications, the disclosure of which
                                                                                                     hereby given of the following meetings.



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Document Created: 2016-06-15 02:21:26
Document Modified: 2016-06-15 02:21:26
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionNotice of public meetings.
DatesSee ``How to Participate in the Public Meetings'' in the SUPPLEMENTARY INFORMATION section of this document for dates, times,
ContactFor questions about registering for this meeting or for special accommodations due to disability, contact Cindy de Sales, The Event Planning Group, 8720 Georgia Ave., Suite 801, Silver Spring, MD 20910, 240-316-3207, FAX: 240-652-6002, and email: [email protected]
FR Citation81 FR 39056 

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